Refer to apixaban Summary of Product Characteristics for further information. Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established providerpatient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction. . There is a full list of potential drug interactions on the Emergency Use Authorization fact sheet for providers on Paxlovid. Its important to note that Paxlovid (the brand name for the drug, which is made up of two generic medicationsnirmatrelvir and ritonavir) isnt the only pill available to treat COVID-19. Updated: Feb. 3, 2023]. In cases where the risks of the drug interaction outweigh the potential benefits, alternative COVID-19 therapy must be prescribed. For patients with renal and/or hepatic impairment. have been reported with PAXLOVID. Among these patients, dysgeusia and diarrhea occurred more frequently in ritonavir-boosted nirmatrelvir recipients than in placebo recipients (6% vs. 0.3% and 3% vs. 2%, respectively). Avoid concomitant use of everolimus and sirolimus and PAXLOVID. Hammond J, Leister-Tebbe H, Gardner A, et al. Tables with guidance on managing specific drug-drug interactions: Increasing monitoring for potential adverse events to the concomitant medication. Copyright 2023 The University of Liverpool. Discontinue use of lovastatin and simvastatin at least 12 hours prior to initiation of PAXLOVID,during the 5 days of PAXLOVID treatment and for 5 days after completing PAXLOVID. Refer to the respective prescribing information for anti-infective dose adjustment. a Reduced effectiveness of clopidogrel is likely. Consult the. Most people who take Paxlovid should not experience serious side effects, explains Dr. Roberts. Below are their responses. Avoid concomitant use of suvorexant with PAXLOVID. An official website of the United States government. Available at: Charness ME, Gupta K, Stack G, et al. Early testing is key to making these drugs work, he says. Pulmonary hypertension agents (sGC stimulators). But in order to qualify for a prescription, you must also have had a positive COVID-19 test result and be at high risk for developing severe COVID-19. Consult Table 1 of the Fact Sheet for Healthcare Providers for clinically significant drug interactions, including contraindicated drugs. The following adverse reactions have been identified during post-authorization use of PAXLOVID. Available at: Ontario Health. Caution is warranted and clinical monitoring of patients is recommended. PAXLOVID must be prescribed by a licensed healthcare provider and supplied by a government-approved pharmacy or medical facility. Therefore, caution should be exercised when administering PAXLOVID to patients with, Because nirmatrelvir is co-administered with ritonavir, there may be a. in individuals with uncontrolled or undiagnosed HIV-1 infection. Note: Information in this article was accurate at the time of original publication. Deo R, Choudhary MC, Moser C, et al. k Dexamethasone exposure is expected to increase 2.60-fold when dexamethasone is coadministered with ritonavir-boosted nirmatrelvir.5 Clinicians should weigh the risks and benefits of continuing the patients normal dose of dexamethasone (while monitoring for AEs) versus decreasing the dose. Coadministration of eletriptan within at least 72 hours of PAXLOVID is contraindicated due to potential for serious adverse reactions including cardiovascular and cerebrovascular events [see Contraindications (4)]. Interacting drugs listed in the Fact Sheet are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID. PAXLOVID TM (nirmatrelvir tablets; ritonavir tablets) has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild-to-moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including . Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Looking for U.S. government information and services. The FDA says that anyone who takes Paxlovid should contact their health provider right away if they have any signs and symptoms of liver problems: loss of appetite, yellowing of the skin and whites of the eyes (jaundice), dark-colored urine, pale-colored stools and itchy skin, or stomach-area (abdominal) pain. Dosage adjustment of tofacitinib is recommended. The Food and Drug Administration's fact sheet on Paxlovid notes an extensive list of drug-drug interactions for health care providers, noting "caution is warranted" with Amlodipine, that "clinical . Patients who are receiving higher doses of dexamethasone will be at a greater risk of AEs. Trazodone and Paxlovid interaction. Available at: Food and Drug Administration. **Tip: If you use CONTROL + F, you can type the name of the drug you are looking to find on the list. of glecaprevir/pibrentasvir with PAXLOVID. Avoid Paxlovid if absolute contraindications identified and holding interaction medication not possible. There are no data on combining ritonavir-boosted nirmatrelvir with other antiviral therapies to treat nonhospitalized patients with COVID-19. The FDA has authorized the emergency use of PAXLOVID for the treatment of adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.. PAXLOVID is still being studied. Drug Interactions. In particular, the results of these studies may be affected by residual confounding. Co-administration of PAXLOVID with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. But in many cases, patients can talk to their doctors about taking a temporary break from some of those drugs while taking Paxlovid, he adds. The EUA advises against crushing nirmatrelvir and ritonavir tablets. c Some PDE5 inhibitors are used to treat both PAH and erectile dysfunction; however, the doses used to treat PAH are higher than those used for erectile dysfunction. The safety and effectiveness of PAXLOVID have not been established in pediatric patients. The prescribing healthcare provider and/or the providers designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to PAXLOVID within 7 calendar days from the healthcare provider's awareness of the event. Coadministration contraindicated due to potential for dehydration, hypovolemia and hyperkalemia [see Contraindications (4)]. o 150 mg nirmatrelvir and 100 mg ritonavir twice daily for 5 days. Paxlovid is the latest COVID-19 treatment thats been all over the news. Bottom line, a glass won't kill you.. immediately. g Withhold lovastatin and simvastatin for at least 12 hours before initiating ritonavir-boosted nirmatrelvir, during treatment, and for 5 days after treatment completion. Consider consulting with an expert (e.g., a pharmacist or the patients specialist providers) when treating patients who are receiving highly specialized therapies or drugs that are prone to concentration-dependent toxicities, such as certain anticonvulsant, anticoagulant, antiarrhythmic, chemotherapeutic, neuropsychiatric, and immunosuppressant drugs. Coadministration contraindicated due to potential for hepatotoxicity and gastrointestinal adverse reactions [see Contraindications (4)]. By selecting continue, you acknowledge you have a medical question regarding a potential drug interaction. tezacaftor/ivacaftor. "The side . Sufficient information is not available to assess renal and hepatic function. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. 2022. Refer to the individual product label for more information. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Imai M, Ito M, Kiso M, et al. elexacaftor/tezacaftor/ivacaftor . They're both necessary parts of treatment. Consider temporary discontinuation of atorvastatin and rosuvastatin during treatment with PAXLOVID. Dosage adjustment of cilostazol is recommended. It is relatively new to the market, and information about its safety and effectiveness is limited. Looking for U.S. government information and services. 2021. Coadministration contraindicated due to potential loss of virologic response and possible resistance. Box 2 below lists select outpatient medications that have clinically relevant drug-drug interactions with ritonavir-boosted nirmatrelvir. Soares H, Baniecki ML, Cardin R, et al. Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.Anaphylaxis and other hypersensitivity reactionshave been reported with PAXLOVID. Paxlovid is an antiviral therapy that consists of two separate medications packaged together. You have to take Paxlovid within five days of developing symptoms. Refer to the upadacitinib product label for more information. 2022. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Providers should counsel patients about renal dosing instructions. PAXLOVID is not authorized for use in pediatric patients younger than 12 years of age or weighing less than 40 kg. Severely immunocompromised patients can experience prolonged periods of SARS-CoV-2 replication, which may lead to rapid viral evolution. If coadministered, refer to individual product label for calcium channel blocker for further information. Refer to the individual immunosuppressant product label for further information and obtain expert consultation from the patients immunosuppressive therapy specialist. diazepam, Nirmatrelvir-ritonavir and viral load rebound in COVID-19. ritonavir and dasabuvir Official websites use .govA .gov website belongs to an official government organization in the United States. Pfizer Inc.; September 26, 2022. Tables with guidance on managing specific drug-drug interactions: Nirmatrelvir must be administered with ritonavir to achieve sufficient therapeutic plasma concentrations. Caution should be exercised when coadministeringPAXLOVID with digoxin, with appropriate monitoring of serum digoxin levels. Fish Oil (omega-3 polyunsaturated fatty acids), Email this report to a friend, doctor, or patient. Dosing recommendations for coadministration of upadacitinib with PAXLOVID depends on the upadacitinib indication. PAXLOVID is not an appropriate therapeutic option based on the authorized Fact Sheet fo r Healthcare Providers or due to potential drug interactions for which recommended monitoring would not . If coadministered, dose adjustment of the immunosuppressant and monitoring for immunosuppressant concentrations and immunosuppressant-associated adverse reactions is recommended. Fewer ritonavir-boosted nirmatrelvir recipients discontinued the study drug due to an adverse event than placebo recipients (2% vs. 4%). Modification of other medications is needed due to a potential drug interaction. Deviation from the recommended strategies may be appropriate in certain clinical scenarios. (eGFR <30 mL/min based on CKD-EPI formula) until more data are available; the appropriate dosage for patients with severe renal impairment has not been determined., Pharmacist Instruction Sheet for Patients with Moderate Renal Impairment, Important Prescribing & Dispensing Letter to Healthcare Professionals (Aug. 2022), Fact Sheet for Patients, Parents, and Caregivers, PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19, Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established providerpatient relationship with the individual patient, to assess renal and hepatic function; and. But people should stop taking Paxlovid and call a health care provider right away if they experience any of the following signs of an allergic reaction: Since Paxlovid is cleared by the kidneys, dose adjustments may be required for patients with mild-to-moderate kidney disease, explains Dr. Topal. However, lovastatin and simvastatin should be switched to an alternative statin. Dosing recommendations for co-administration of apixaban with Paxlovid depend on the apixaban dose. The healthcare provider should consult other appropriate Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring.Nirmatrelvir and ritonavir are CYP3A substrates; therefore, drugs that induce CYP3A may decrease nirmatrelvir and ritonavir plasma concentrations and reduce PAXLOVID therapeutic effect.Pregnancy: There are no available human data on the use of nirmatrelvir during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Patients who were randomized within 3 days of symptom onset (n = 1,379) were included in the modified intention-to-treat (mITT) analysis. an altered or impaired sense of taste. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19., Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. buspirone, Drug-Drug Interactions with Nirmatrelvir/Ritonavir (Paxlovid) and Select Cardiovascular Medications NOTE: Holding or reducing the dose of select cardiovascular medications and/or other special monitoring requirements are recommended during treatment with nirmaltrelvir/ritonavir (Paxlovid) and for 3 days thereafter (for a total of 8 days from the For guidance on managing these interactions, refer to the FDA EUA fact sheet and the prescribing information for the chemotherapeutic agent. If withholding a statin is not clinically appropriate (e.g., because the patient recently had a myocardial infarction), clinicians can reduce the doses of atorvastatin and rosuvastatin and continue treatment.
